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Full Text of this Amendment

SA 1053. Mr. ENZI (for himself, Mr. Kennedy, Mr. Dodd, and Mrs. Clinton) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

On page 226, line 4, strike ``later'' and insert ``if the determination made under subsection (d)(3) is made less''.
On page 228, line 3, strike ``later'' and insert ``if the determination made under subsection (d)(3) is made less''.
On page 233, line 12, insert ``, such as expertise in child and adolescent psychiatry,'' after ``expertise''.
On page 233, line 15, strike ``including'' and insert ``which may include''.
On page 233, between lines 18 and 19, insert the following:
``(C) ACTION BY COMMITTEE.--The committee established under this paragraph may perform a function under this section using appropriate members of the committee under subparagraph (B) and need not convene all members of the committee under subparagraph (B) in order to perform a function under this section.
``(D) DOCUMENTATION OF COMMITTEE ACTION.--The committee established under this paragraph shall document for each function under paragraphs (2) and (3), which members of the committee participated in such function.
On page 234, line 1, strike ``determine'' and insert ``make a recommendation to the Secretary''.
On page 235, line 2, strike ``and''.
On page 235, line 6, strike ``.'';'' and insert ``; and''
On page 235, between lines 6 and 7, insert the following:
``(H) the number of times the committee established under paragraph (1) made a recommendation to the Secretary under paragraph (3), the number of times the Secretary did not follow such a recommendation to accept reports under subsection (d)(3), and the number of times the Secretary did not follow such a recommendation to reject such reports under section (d)(3).
``(5) COMMITTEE.--The committee established under paragraph (1) is the committee established under section 505B(f)(1).'';
On page 260, lines 17 through 19, strike ``of a letter, or a written request under section 505A that was declined by the sponsor or holder'' and insert ``of a written request under section 505A that was declined by the sponsor or holder, or a letter referencing such declined written request,''.
On page 261, line 3, strike ``appropriate'' and insert ``appropriate, for the labeled indication or indications,''.
On page 263, line 14, insert ``, such as expertise in child and adolescent psychiatry,'' after ``expertise''
On page 263, between lines 19 and 20, insert the following and redesignate the remaining paragraphs accordingly:
``(2) ACTION BY THE COMMITTEE.--The committee established under paragraph (1) may perform a function under this section using appropriate members of the committee under paragraph (1) and need not convene all members of the committee under paragraph (1) in order to perform a function under this section.
``(3) DOCUMENTATION OF COMMITTEE ACTION.--For each drug or biological product, the committee established under this paragraph shall document for each function under paragraph (4) or (5), which members of the committee participated in such function.
On page 265, between lines 18 and 19, insert the following:
``(7) COMMITTEE.--The committee established under paragraph (1) is the committee established under section 505A(f)(1).
On page 289, line 16, strike ``
SURVEILLANCES'' and insert ``POSTMARKET SURVEILLANCE''.
On page 289, line 17, strike ``Surveillances'' and insert ``Surveillance''.
On page 290, strike lines 9 through 12 and insert the following:
``(iii) that is intended to be--
``(I) implanted in the human body for more than 1 year; or
``(II) a life-sustaining or life-supporting device used outside a device user facility.
On page 290, line 15, strike ``of an'' and all that follows through ``section 510(k) only for'' on line 19, and insert ``or clearance of''.

(As printed in the Congressional Record for the Senate on May 7, 2007.)